[Federal Register Volume 71, Number 174 (Friday, September 8, 2006)]
[Notices]
[Pages 53095-53096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-7510]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Public Meeting on Patient and Physician Concerns in Access to 
Intravenous Immunoglobulin (IVIG)

AGENCY: Department of Health and Human Services, Office of the 
Assistant Secretary for Planning and Evaluation (HHS/ASPE).

ACTION: Notice of Meeting.

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SUMMARY: This notice announces the date and location of a Town Hall 
meeting to be held on September 28, 2006 to obtain public comment on 
patient and physician concerns with access to IVIG. The Department of 
Health and Human Services, Office of the Assistant Secretary for 
Planning and Evaluation has contracted with Eastern Research Group, 
Inc. (ERG) to develop an analysis of supply, distribution, demand, and 
access issues associate with IVIG. This public meeting provides a forum 
for interested parties to make oral comments and to submit written 
comments about IVIG access for use in the analysis. In particular, 
comments are invited that will aid in the analysis of any physician or 
patient problems with access to IVIG, including the nature, size, and 
scope of any problems, as well as estimation of changes in health 
outcomes that may result from access problems.

DATES: The Town Hall meeting will be held on September 28, 2006 from 10 
a.m. to 5 p.m.

ADDRESSES: Sheraton Crystal City Hotel, 1800 Jefferson Davis Highway, 
Arlington, VA.

FOR FURTHER INFORMATION CONTACT: Amber Jessup. Office of the Assistant 
Secretary for Planning and Evaluation, 200 Independence Ave., SW., 
Washington, DC 20201. Telephone: 202-690-6621.
    Web site: Additional details regarding the Town Hall meeting 
process for public comments, along with information on how to register 
and guidelines for an effective presentation and/or electronic comment 
submission, can be found on the project Web site at https://www2.ergweb.com/projects/conferences/hhs.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Department of Health and Human Services, Office of the 
Assistant Secretary for Planning and Evaluation has contracted with 
Eastern Research Group, Inc. (ERG) to develop an analysis of supply, 
distribution, demand, and access issues associated with IVIG. As part 
of this analysis, a Town Hall meeting is being scheduled to obtain 
public comment on access issues to be used in the analysis.
    Intravenous Immune Globulin (IVIG) is a plasma product that is used 
to treat patients with immune system disorders. Immune globulins are 
antibodies. IVIG has a number of on-label uses including treatment of 
humoral immunodeficiency, acute and chronic idiopathic thrombocytopenia 
purpura, B cell chronic lymphocytic leukemia (to prevent recurrent 
bacterial infections), Kawasaki disease, pediatric HIV, and bone marrow 
transplantation. It is also used for off-label treatments including 
autoimmune, neurological, and systemic inflammatory conditions. 
According to the Department of Health and Human Services Advisory 
Committee on Blood Safety and Availability, more than half of IVIG use 
may be for off-label indications. Due at least in part to the increase 
in off-label uses, demand for IVIG has increased in recent years. The 
number of infusion days in hospitals increased to 70,000 days in 2004 
from 40,000 days in 2002 and the number of grams infused in physician 
offices increased by 1.7 million grams, between 2003 and 2004, from 2.3 
to 4.0 million grams.
    IVIG is covered under Medicare Part B. In 2005, Medicare shifted 
from Average Wholesale Price (AWP) as the basis for reimbursement to 
Average

[[Page 53096]]

Sales Price (ASP) as required by the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (MMA). This shift reduced 
the reimbursement amount to physicians by 35 percent for the powder 
form of IVIG and by 15 percent for the liquid form of IVIG. Since 
January 2005, some patient advocacy groups and physicians have reported 
difficulty acquiring IVIG. The FDA Center for Biologics Evaluation and 
Research, however, has not identified a shortage of IVIG. There have 
also been reports of IVIG being diverted to secondary markets with 
increases in prices.
    The focus of the Town Hall meeting is on receiving information from 
stakeholders that will be helpful in the analysis. The Town Hall 
meeting will accept comments from all stakeholders, but is focused on 
patient and physician concerns with access to IVIG including:
    (1) Patients switching IVIG products due to access problems,
    (2) Changes in the administration location,
    (3) Patients receiving fewer treatments,
    (4) Patients receiving reduced dosages, and
    (5) Reimbursement problems with IVIG products,
    (6) Patients receiving reduced dosages, and
    (7) Health consequences for patients of any access issues.

II. Registration

    Registration procedures: Registration can be completed online at 
https://www2.ergweb.com/projects/conferences/hhs/. To register by 
telephone, contact ERG's Conference Registration Line at 781-674-7374. 
The following information must be provided when registering: Name, 
organization name and address (if applicable), and consent to publish 
contact information on a participants list and other reports to 
document the Town Hall meeting. An ERG staff member will confirm your 
registration by mail, e-mail, or fax. Attendees may participate in 
person or by phone. If you wish to participate by phone, please 
indicate this in your registration and a call-in conference number will 
be provided in your registration confirmation. Attendees must register 
by September 21.

III. Comment Format

a. ``5-Minute'' Public Comment

    Meeting attendees can sign up on a first-come, first-served basis 
to present their comments (maximum of 5 minutes) via the meeting Web 
site when you register. Comments may be made in person or by phone. 
Commenters should focus on issues related to access to IVIG and 
quantify these impacts when possible. Commenters must provide their 
name, title, and organization (if applicable) on their registration and 
identify the topic area they will address. Presenters that can not 
attend in person can participate via phone. If you are unable to attend 
in person, you should indicate at registration that you wish to 
participate via phone. A call-in conference number will be provided to 
you in your registration confirmation.

b. Written Comments From Meeting Attendees

    Written comments are welcome from the public regardless of whether 
you attend the Town Hall Meeting or whether you make an oral 
presentation at the Town Hall Meeting. Written comments can be 
submitted either at the meeting, or before or after the meeting via e-
mail to [email protected] (subject: IVIG Meeting Comments). Or via 
regular mail to Attn: IVIG Meeting, ERG, 110 Hartwell Avenue, 
Lexington, MA 02421. Please note that electronic submissions are 
preferred due to delays in receiving US Postal Mail. We are able to 
consider only those comments received in writing and/or via e-mail by 5 
p.m. EST on October 15, 2006.

IV. Special Accommodations

    Individuals attending the meeting who are hearing- or visually-
impaired and have special requirements, or a condition that requires 
special assistance or accommodations, must provide this information 
when registering for the meeting and accommodations will be made.

    Dated: August 31, 2006.
Jerry Regier,
Principal Deputy Assistant Secretary for Planning and Evaluation, 
Office of the Assistant Secretary for Planning and Evaluation.
[FR Doc. 06-7510 Filed 9-7-06; 8:45 am]
BILLING CODE 4151-06-M